Digital Quality & GxP Manager

Role overview Guide digital quality and GxP compliance for software, systems, and AI products across their lifecycle. You will help manage regulatory risk, support product and quality teams with practical guidance, and maintain quality processes for internal and external offerings in a fast-moving SaaS environment.

Responsibilities - Review and approve validation activities for software and AI products against regulatory requirements and internal policies. - Prepare for external regulatory audits and lead internal or vendor audits related to GxP and regulatory compliance. - Develop and maintain digital quality-system components, including processes for AI quality management. - Monitor systems and processes for adherence to procedures, audit expectations, and industry practices. - Assess vendors against digital quality requirements and advise stakeholders on findings. - Train colleagues on quality processes and best practices, and take on quality projects as assigned.

Requirements - At least 3 years implementing GxP standards and advising on quality compliance at a SaaS company, including validation of GxP systems. - Experience with Good Clinical Practice. - Demonstrated leadership in software-industry compliance programs; project management experience is preferred. - Familiarity with SaaS applications and agile product development. - Technical understanding of data management in healthcare or clinical-trial settings. - Strong communication, analytical, organizational, and time-management skills, including the ability to manage competing deadlines with limited supervision.

Nice to have Certifications in GxP quality, computer systems validation, or quality-systems management are preferred.

Benefits and work setup Remote within the United States, with planned travel of up to 40%. The listed annual pay range is $110,000–$140,000 for full-time employees. Benefits include paid time off and holidays, employer-paid medical, dental, and vision options, HSA and FSA plans, disability coverage, and a 401(k) with employer match.